rTMS for Neuropathic Pain After Spinal Cord Injury

Overseen By Melanie H Vergeer, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Pacemaker, Metallic implant, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 21

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a non-invasive treatment called repetitive transcranial magnetic stimulation (rTMS) can reduce pain for individuals with nerve pain following a spinal cord injury. rTMS uses magnetic fields to stimulate specific brain areas, and participants will undergo these sessions over four weeks. The trial seeks individuals diagnosed by a doctor with a spinal cord injury who have experienced neuropathic pain for at least three months, affecting daily activities. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new pain management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for treating neuropathic pain after spinal cord injury?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for people. This non-invasive technique uses magnets to stimulate the brain. Studies have found it carries a low risk of side effects. While rTMS can help manage pain, one study found it was not more effective than a placebo for some types of pain. However, it remains well-tolerated. Most people do not experience serious side effects. Some might feel mild discomfort or a headache, but these usually resolve quickly. Overall, rTMS is considered a safe option for those looking to reduce nerve-related pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it offers a non-invasive approach to manage neuropathic pain after spinal cord injury by using magnetic fields to stimulate nerve cells in the brain. Unlike traditional treatments like medications that target the symptoms of pain, rTMS focuses directly on altering brain activity in the dorsolateral prefrontal cortex, which can help modulate pain perception. Researchers are excited about this treatment because it can be precisely targeted and adjusted to each individual's needs, potentially offering pain relief with fewer side effects compared to conventional pharmaceutical options.

What evidence suggests that rTMS is effective for neuropathic pain after spinal cord injury?

Research has shown that the effectiveness of repetitive transcranial magnetic stimulation (rTMS) for treating nerve pain after a spinal cord injury remains unclear. In this trial, participants will undergo rTMS sessions to evaluate its potential benefits. Some studies suggest that rTMS can relieve this type of pain without surgery. However, other research found that rTMS did not outperform a placebo for individuals with nerve pain from spinal cord injuries. This mixed evidence indicates that while rTMS might help some people, its effectiveness can vary. More research is needed to confirm its benefits for this specific pain. ^{1 2 4 6 7}

Who Is on the Research Team?

Chantel T Debert, MD MSc FRCPC CSCN

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with neuropathic pain lasting at least 3 months due to a spinal cord injury. Candidates must not have other conditions causing the pain, no prior TMS therapy, and no contraindications like pacemakers, metal implants in the head, seizures, severe psychiatric disorders, or uncontrolled major diseases.

Inclusion Criteria

I have been diagnosed with nerve pain for at least 3 months.

I have a spinal cord injury diagnosed by a doctor.

My pain is only due to my current health condition.

Exclusion Criteria

I have previously undergone TMS therapy.

I do not have a pacemaker, metal implants, serious brain issues, seizures, severe mental health issues, recent suicide attempts, liver or kidney disease, cancer, uncontrolled high blood pressure or diabetes, and I am not pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo high frequency rTMS sessions 5 days a week for 4 weeks

4 weeks

20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Assessments at 1 month and 3 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview

The study tests whether repetitive Transcranial Magnetic Stimulation (rTMS) can relieve neuropathic pain in individuals who've suffered a spinal cord injury. rTMS is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain.

How Is the Trial Designed?

Group I: Repetitive Transcranial Magnetic Stimulation (rTMS) Experimental Treatment 1 Intervention

Participants will undergo high frequency rTMS sessions 5 days a week for 4 weeks (20 treatments total). Treatment intensity will be applied at 100-120% of the participant's resting motor threshold. The neurostimulation protocol will be 10 trains of 60 pulses (600 pulses total) at a frequency of 10 Hz, with inter-train interval of 45-seconds. The rTMS will be administered to the dorsolateral prefrontal cortex (DLPFC) which will be located using Montreal Neurologic Institute (MNI) coordinates (-50, 30, 36) on a standardized brain. Participants will be seated in a comfortable chair or their wheelchair for each rTMS session.

Repetitive Transcranial Magnetic Stimulation (rTMS) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as rTMS for:

• Depression
• Smoking cessation

Approved in European Union as rTMS for:

• Depression

Approved in Canada as rTMS for:

• Depression

Approved in Japan as rTMS for:

• Depression

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

A study involving 66 patients with neuropathic pain showed that high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) targeting the specific pain region using navigation techniques provided significant pain relief, particularly for upper and lower limb pain.

The pain relief from navigated rTMS lasted for one week, indicating that navigation may enhance the efficacy of rTMS compared to traditional non-navigated methods, although it was less effective for facial or diffuse pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic effects of navigated motor cortex rTMS in patients with chronic neuropathic pain. Ayache, SS., Ahdab, R., Chalah, MA., et al.[2022]

Motor cortex stimulation can effectively control neuropathic pain in many patients, and repetitive transcranial magnetic stimulation (rTMS) can provide analgesic effects as well.

In a reported case, a woman with drug-resistant peripheral pain experienced 16 months of pain relief from monthly rTMS sessions before receiving a surgical cortical stimulator, highlighting rTMS as a valuable interim treatment before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropathic pain controlled for more than a year by monthly sessions of repetitive transcranial magnetic stimulation of the motor cortex. Lefaucheur, JP., Drouot, X., Ménard-Lefaucheur, I., et al.[2011]

In a study involving 17 patients with spinal cord injury and chronic neuropathic pain, repetitive transcranial magnetic stimulation (rTMS) did not show a significant advantage over sham treatment in reducing pain levels, indicating that its analgesic effect may not be superior to placebo.

Despite the lack of significant difference compared to sham treatment, rTMS did provide encouraging pain relief at 10 days and 6 weeks post-treatment, suggesting potential for further research with larger sample sizes to explore its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of repetitive transcranial magnetic stimulation on refractory neuropathic pain in spinal cord injury. Yılmaz, B., Kesikburun, S., Yaşar, E., et al.[2021]

Repetitive transcranial magnetic stimulation (rTMS) applied to the M1/S1 cortex significantly lowers μ-opioid receptor availability, indicating the release of endogenous opioids in various brain regions associated with pain processing, which may contribute to its pain-relieving effects.

Despite the activation of the endogenous opioid system, rTMS did not change thermal pain thresholds or sensory discrimination of painful stimuli, suggesting that while rTMS enhances opioid-mediated inhibition, it does not alter the perception of pain intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurotransmitters behind pain relief with transcranial magnetic stimulation - positron emission tomography evidence for release of endogenous opioids. Lamusuo, S., Hirvonen, J., Lindholm, P., et al.[2018]

High-frequency repetitive transcranial magnetic stimulation (HF-rTMS) is effective in reducing neuropathic pain, with significant pain relief observed after just one and five treatment sessions, based on a meta-analysis of 25 studies involving 589 patients.

The analgesic effects of HF-rTMS can last for at least one month after five sessions, indicating its potential for long-term pain management in neuropathic pain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Frequency Repetitive Transcranial Magnetic Stimulation Therapy For Chronic Neuropathic Pain: A Meta-analysis. Jin, Y., Xing, G., Li, G., et al.[2018]

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